Compositions and methods for detecting or quantifying hepatitis B virus
AssigneeGen-Probe Incorporated
InventorsKui Gao, Jeffrey M. Linnen
Life of this patent
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Abstract
This disclosure provides oligomers, compositions, and kits for detecting and quantifying Hepatitis B virus (HBV), including different genotypes and variants thereof, and related methods and uses. In some embodiments, oligomers target the P and/or S open reading frames of HBV and are configured to provide substantially equivalent quantification of different genotypes and variants of HBV.
Claims14
A method of determining a concentration of Hepatitis B virus in a sample comprising first and second Hepatitis B amplicons in the presence of a first probe oligomer configured to specifically hybridize to the first amplicon and a second probe oligomer configured to specifically hybridize to the second amplicon, wherein the first probe oligomer is attached to a first label and the second probe oligomer is attached to a second label, respectively, wherein at least one of the first label and the second label is a non-nucleotide detectable label, wherein the second amplicon comprises at least 10 contiguous nucleotides of SEQ ID NO:
- 35, including the inosine at position 30 of SEQ ID NO:
- 35, the method comprising:
- (i) detecting a first signal emitted from the first label;
- (ii) detecting a second signal emitted from the second label;
- (iii) determining whether the first signal or the second signal is above a predetermined threshold;
- and
- (iv) calculating the concentration of Hepatitis B virus in the sample,
- wherein if the first signal or the second signal is above the predetermined threshold, the concentration is calculated from the greater of the first and second signals;
- wherein if the first signal and the second signal are below the predetermined threshold, the concentration is calculated from an average of the first and second signals;
- and
- wherein the predetermined threshold corresponds to a concentration in the range of about 10 IU/ml to about 200 IU/ml.
Dependencies are inferred from the claim text.